Clinical trial · Interventional
Six Versus Twelve Month Index Follow-up After Large Colon Polyp Resection
Six Versus Twelve Month SurveillAnce Following Resection of Nonpedunculated ColorectaL Polyps 20-50 mm IN Size Without High Grade Dysplasia (HGD)
NCT07198945CI-TRIAL-00115092STARLINGenrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study will compare the use of a 6-month follow-up vs a 12-month follow-up after the removal of a large non-pedunculated polyp 20-50mm in size and without high grade dysplasia.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colon Polyp | — | UNRESOLVED | — |
| Endoscopic Resection | — | UNRESOLVED | — |
| Recurrence, Local Neoplasm | — | UNRESOLVED | — |
| Serrated Polyp | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 12-month follow-up | Procedure | — | UNRESOLVED |
| 6-month follow-up | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 6-month follow-up
- description
- Patients will be recommended to complete their first surveillance procedure 6 months after the large polyp removal procedure in order to assess whether the polyp grew back.
- interventionNames
- Procedure: 6-month follow-up
- type
- EXPERIMENTAL
- label
- 12-month follow-up
- description
- Patients will be recommended to complete their first surveillance procedure 12 months after the large polyp removal procedure in order to assess whether the polyp grew back.
- interventionNames
- Procedure: 12-month follow-up
Primary outcomes (1)
- measure
- Rate of recurrence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patient Criteria 1. ≥ 18 years of age 2. Ability to provide informed consent 3. Willing and able to complete one electronic survey 4. Presenting for colonoscopy for any indication 5. Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments. Polyp Criteria 6. Size 20-50 mm as documented with photo containing open snare of known size as comparison. 7. Histology without high grade dysplasia: 1. Conventional Adenoma: adenoma with or without villous components 2. Serrated: hyperplastic or sessile serrated lesion Exclusion Criteria: Patient Criteria 1. Patients with confirmed diagnosis of inflammatory bowel disease, including Ulcerative Colitis and Crohn's Disease. 2. Patients with a known or suspected diagnosis of any of the following polyposis or non-polyposis syndromes with known genetic mutations: * Familial Adenomatous Polyposis Syndrome * MUTYH associated Polyposis Syndrome * Juvenile Polyposis Syndrome * Cowden's Syndrome * Peutz-Jeghers Syndrome * Hereditary Non-Polyposis Colorectal Cancer Syndrome (HNPCC) or Lynch Syndrome 3. Patients who have high grade dysplasia found in any polyp ≥ 20 mm removed at the index colonoscopy 4. Patients who have any colorectal cancer by histologic diagnosis at index procedure 5. Patients needing a colonoscopy 6 months or sooner for any indication following the index procedure including burden of synchronous disease, inadequate prep to assess for synchronous disease, inadequate prep that precludes resection of index large polyp, or other reason limiting ability to complete full examination of colon at time of resection. 6. ASA ≥ 4 or documented coagulopathy or severe thrombocytopenia (INR ≥ 2 or platelets ≤ 20). 7. Patients who have more than three ≥ 20mm polyps removed during the index colonoscopy 8. Patients with significant acute or chronic medical, neurologic, or illness that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study. Polyp Criteria 9. Polyp located at appendiceal orifice, ileocecal valve, or intradiverticulum 10. Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp) 11. A polyp that is classified as a traditional serrated adenoma. 12. Polyps with features of invasive cancer 13. Polyps that are not able to be removed with standard endoscopic techniques for any reason 14. Polyps that are incompletely resected endoscopically at index procedure 15. Polyps removed by endoscopic submucosal dissection (ESD) or by full thickness resection device (FTRD)
References
Publications (12)
- BACKGROUNDKaltenbach T, Anderson JC, Burke CA, Dominitz JA, Gupta S, Lieberman D, Robertson DJ, Shaukat A, Syngal S, Rex DK. Endoscopic Removal of Colorectal Lesions-Recommendations by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1095-1129. doi: 10.1053/j.gastro.2019.12.018. Epub 2020 Feb 11. No abstract available. PMID 32122632
- BACKGROUNDGupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1131-1153.e5. doi: 10.1053/j.gastro.2019.10.026. Epub 2020 Feb 7. No abstract available. PMID 32044092
- BACKGROUNDEl Rahyel A, Abdullah N, Love E, Vemulapalli KC, Rex DK. Recurrence After Endoscopic Mucosal Resection: Early and Late Incidence, Treatment Outcomes, and Outcomes in Non-Overt (Histologic-Only) Recurrence. Gastroenterology. 2021 Feb;160(3):949-951.e2. doi: 10.1053/j.gastro.2020.10.039. Epub 2020 Oct 29. No abstract available. PMID 33130101
- BACKGROUNDTate DJ, Desomer L, Argenziano ME, Mahajan N, Sidhu M, Vosko S, Shahidi N, Lee E, Williams SJ, Burgess NG, Bourke MJ. Treatment of adenoma recurrence after endoscopic mucosal resection. Gut. 2023 Oct;72(10):1875-1886. doi: 10.1136/gutjnl-2023-330300. Epub 2023 Jul 6. PMID 37414440
- BACKGROUNDMohapatra S, Almazan E, Charilaou P, et al. Outcomes of Endoscopic Resection for Colorectal Polyps With High-Grade Dysplasia or Intramucosal Cancer. Techniques and Innovations in Gastrointestinal Endoscopy 2023;25:119-126.
- BACKGROUNDParsa N, Ponugoti P, Broadley H, Garcia J, Rex DK. Risk of cancer in 10 - 19 mm endoscopically detected colorectal lesions. Endoscopy. 2019 May;51(5):452-457. doi: 10.1055/a-0799-9997. Epub 2019 Jan 8. PMID 30620947
- McWhinney CD, Vemulapalli KC, El Rahyel A, Abdullah N, Rex DK. Adverse events and residual lesion rate after cold endoscopic mucosal resection of serrated lesions >/=10 mm. Gastrointest Endosc. 2021 Mar;93(3):654-659. doi: 10.1016/j.gie.2020.08.032. Epub 2020 Sep 3.